510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Medical Specialties Inc.

Wadesboro, NC, US

MEDICAL SPECIALTIES INC. appears in FDA device records in Wadesboro, NC. FDA records list 40 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
40
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 40 510(k) clearances for Medical Specialties Inc. between 1979 and 1995. The busiest year on record is 1984, with 23. The most recent is 1995, with 1.

Clearances by year, as a table
510(k) clearance decisions for Medical Specialties Inc., by decision year
YearClearances
19792
19831
198423
19851
19861
19872
19885
19901
19933
19951
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K946201STAND, INFUSIONFOXSubstantially Equivalent
K931947CHECKPOINTJPKSubstantially Equivalent
K926095REFRACTROL-SPJJXSubstantially Equivalent
K924926MSI-HCTGLKSubstantially Equivalent
K896566MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVEJWYSubstantially Equivalent
K883851MSI-CAL 8KRZSubstantially Equivalent
K883850MSI-CAL 16KRZSubstantially Equivalent
K883703MSI-CAL 7KRZSubstantially Equivalent
K880608MSI-PCGJPSubstantially Equivalent
K880270MSI-DIFF PLUSJPKSubstantially Equivalent
K872140(MSI) PATH-SAVERIFPSubstantially Equivalent
K871067MSI HEMATOLOGY CONTROL +JPKSubstantially Equivalent
K860501FLAME PHOTOMETER STANDARDJLJSubstantially Equivalent
K853776MSI-HB HEMOGLOBIN CONTROLJPKSubstantially Equivalent
K841070CREATININE REAGENT SETJFYSubstantially Equivalent
K841069SERUM TOTAL PROTEIN REAGENT SETCEKSubstantially Equivalent
K841068UREA NITROGEN REAGENT SETCDWSubstantially Equivalent
K841067URIC ACID REAGENT SETCDHSubstantially Equivalent
K841066SGOT-UV REAGENT SETCITSubstantially Equivalent
K841065SGOT REAGENT SETCIQSubstantially Equivalent
K841064ALKALINE PHOSPHOTASE REAGENT SETCIOSubstantially Equivalent
K841063ALBUMIN REAGENT SETCIXSubstantially Equivalent
K841062TRIGLYCERIDE REAGENT SETCDTSubstantially Equivalent
K841061PHOPHORUS REAGNET SETCEOSubstantially Equivalent
K841060SGPT REAGENT SETCKASubstantially Equivalent
K841059SGPT REAGENT SETCKDSubstantially Equivalent
K841058LDH-UV REAGENT SETCFJSubstantially Equivalent
K841056HDL PRECIPITANT REAGENT SETJHMSubstantially Equivalent
K841055GLUCOSE ENZYMATIC REAGENT SETCGASubstantially Equivalent
K841054DIRECT GLUCOSE REAGENT SETCGESubstantially Equivalent
K841053CHOLESTEROL REAGENT SET ENZYMATICCHHSubstantially Equivalent
K841052CHOLESTEROL REAGENT SETCHDSubstantially Equivalent
K841051SERUM CALCIUM REAGENT SETCICSubstantially Equivalent
K841050TOTAL BILIRUBIN REAGENT SETCIGSubstantially Equivalent
K841049URIC ACID REAGENT SET ENZYMATICKNKSubstantially Equivalent
K841057HEMOGLOBIN REAGENT SETGKRSubstantially Equivalent
K834043MSI-HC HEMATOLOGY CONTROLJPKSubstantially Equivalent
K831300MSI-NAK-50 TEST KITJGMSubstantially Equivalent
K791831PROCASTITGSubstantially Equivalent
K791363KWIK-AWA VESTDRGSubstantially Equivalent

Registered establishments

FDA registered establishments for Medical Specialties Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10669593003434195MEDICAL SPECIALTIES INC.3874 South Alston Ave, DURHAM, NC 27713 US2026
10164981016498MEDICAL SPECIALTIES, INC.308 Parson Street, WADESBORO, NC 28170 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain